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| Name | Class |
|---|---|
| Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital | OTHER |
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The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or less is a standard treatment approach since it reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory distress syndrome (RDS) management, providing optimal lung volumes in the very early period from the beginning of delivery room approaches probably augments the expected lung protective effect. Although the benefits of CPAP support are well known, standart CPAP pressures recommended in the guidelines may not meet the needs of individual babies. Maintaining lung patency in the delivery room is the main mechanism of action of CPAP and the requirement may vary individually depending on lung physiology.
In this multicenter randomized controlled study, we aimed to compare the effects of CPAP therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement in preterm babies with RDS in the delivery room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| openCPAP | Active Comparator | Immediately after birth, early nCPAP will be started with a nasal mask with a T-piece resuscitator with 8 cm H2O pressure and 0.30 fiO2. The heart rate (HR) and preductal saturation (SpO2) will be evaluated every 30 seconds. Individually, the following steps will be done according to the situation:
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| standardCPAP | Active Comparator | Immediately after birth, early nCPAP will be started with a nasal mask with T-piece resuscitator at 6 cmH2O pressure and 0.30 fiO2. HR and preductal saturation will be evaluated every 30 seconds. The following steps will be performed according to the situation:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| openCPAP | Procedure | Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of invasive mechanical ventilation | Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV) | First 72 hours after the intervention |
| Incidence of Surfactant therapy | Surfactant therapy requirement | First 72 hours after the intervention |
| SpO2 at 5th minute | The oxygen saturation of the blood at 5 th minute | 5 minute after the delivery |
| SpO2 at 10th minute | The oxygen saturation of the blood at 10 th minute | 5 minute after the delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pneumothorax | Incidence of pneumothorax during intervention and within 24 hours | First 24 hours after the intervention |
| Incidence ofIVH (Grade 3-4) | Intraventricular hemorrhage (IVH) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Ozkan, Prof. | Dokuz Eylül University- Faculty of Medicine | Principal Investigator |
| Nuray Duman, Prof. | Dokuz Eylül University- Faculty of Medicine | Study Director |
| Funda Tuzun, Assoc.Prof. | Dokuz Eylül University- Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik Zubeyde Hanım Maternity and Children Hospital | Ankara | Turkey (Türkiye) | ||||
| Dokuz Eylul University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41247385 | Derived | Duman N, Durukan Tosun M, Tuzun F, Egeli T, Bas AY, Pamukcu MM, Deliloglu B, Akyildiz C, Armagan C, Keskinoglu P, Demirel N, Ozkan H. Non-invasive open lung strategy in delivery room: randomized controlled trial (OpenCPAP-DR). Eur J Pediatr. 2025 Nov 17;184(12):766. doi: 10.1007/s00431-025-06613-8. |
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| standardCPAP |
| Procedure |
Randomized to : Standard level CPAP between 6-8 cmH2O pressure |
|
| First 72 hours after the intervention |
| Duration of ventilatory support (non-invasive) | Duration of non-invasive MV (days) | During first hospitalisation ( an average of 10 weeks) |
| Duration of invasive ventilatory support | Duration of invasive MV ( days) | During first hospitalisation ( an average of 10 weeks) |
| Duration of oxygen (O2) | Duration of O2 treatment (days) | During hospitalisation ( an average of 10 weeks) |
| Incidence of Surfactant treatment | Mean number of surfactant treatment | During hospitalisation (an average of 10 weeks) |
| Bronchopulmonary dysplasia (BPD) | Incidence of BPD | At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first |
| Mortality | Death or composite outcome death/BPD | through study completion (an average of 10 weeks) |
| Izmir |
| 35340 |
| Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
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